NCT07166341已完成不适用
Accuracy Performance Verification of the INVOS™ PM7100 System, Comparing rSO2 Values to Reference Blood Oxygen Saturation Measurements in Adult Human Volunteers
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Accuracy in terms of the root mean square error
研究概览
简要总结
Prospective, observational, pre-market, verification study to confirm accuracy of the INVOS 7100 system in compliance with ISO 80601-2-85:2021 standard
详细描述
Verify that the INVOS PM7100 system in conjunction with the INVOS Adult Sensors meets the requirements for tissue saturation accuracy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 46 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects between the ages of ≥18 to <47 years
- •Completion of a health screening for medical history by a licensed physician, nurse practitioner, or physician assistant
- •Subject is a non-smoker or has not smoked within 2 days prior to the study
- •Minimum weight 40kg
- •BMI within range 18.0-- 35.0
- •Reference tissue hemoglobin oxygen saturation over the range 50% to 85%
排除标准
- •Compromised circulation, injury, or physical malformation of fingers, hands, or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study (Note: certain malformations may still allow subjects to participate if the condition is noted and would not affect the sites utilized)
- •Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain) [self-reported]
- •Prior known severe allergies to medical grade adhesive/tape (Band-Aid) [self-reported]
- •Subjects taking certain medication(s) beyond birth control may be excluded from participating at the PI discretion [self-reported]
- •Subject participation will be at the PI's discretion if they are currently participating in, or if they have recently participated in (discontinued within 30 days prior to the hypoxia procedure for this study) in an investigational drug, device, or biologic study [self-reported]
- •Negative Allen's test for radial and ulnar patency
- •Has made a whole blood donation or has had at least 450 ml of blood drawn within 8 weeks prior to the study procedure [self-reported]
- •Individuals of childbearing potential who are pregnant, who are trying to get pregnant, or who have a urine test positive for pregnancy on the day of the study and is unwilling to use effective birth control between the time of screening and study procedure, or is breastfeeding.
- •Has anemia [lab values specific for gender]
- •Has a history of sickle cell trait or thalassemia [self-reported]
- •Has an abnormal hemoglobin electrophoresis test [lab measurement]
- •Has a positive urine cotinine test or urine drug screen or oral ethanol test [Point of Care (POC) testing]
- •Has a room air saturation less than 95% by pulse oximetry [measurement by PI or delegate]
- •Has a clinically significant abnormal ECG [assessment by PI or delegate]
- •Has a clinically significant abnormal pulmonary function test via spirometry [assessment by PI or delegate]
- •Has a COHb greater than 3%, or MetHb greater than 2% [measured by venous blood sample co-oximetry]
- •Has tHb < 10 g/dl as assessed by co-oximetry during the procedure
研究组 & 干预措施
Healthy Volunteers
Healthy, non-smoking volunteers ages ≥18 to <47 years who meet inclusion criteria
干预措施: Observational (Device)
结局指标
主要结局
Accuracy in terms of the root mean square error
时间窗: Performance evaluation is expected take approximately 2.5 hours
Performance assessed by comparing INVOS™ rSO2 to the calculated global field saturation (fSO2) value obtained from simultaneous arterial and jugular venous blood samples during normocapnia.
次要结局
- Trend accuracy(Evaluation is expected take approximately 2.5 hours)
- Trend accuracy in a hypercapneic state(Evaluation is expected take approximately 2.5 hours)
研究者
研究点 (1)
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